Dose Finding Study Clinical Trial
Official title:
Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
This is a phase I, randomized, single-blind, parallel group, placebo-controlled,
multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of
Cilastatin as stand-alone in healthy male and female volunteers.
The study objectives are:
The evaluation of safety and tolerability of single intravenous doses of cilastatin in
healthy volunteers administered as a 3-hour infusion.
The evaluation of the pharmacokinetic characteristics of Cilastatin after a single 3-hour
infusion dose.
The study is designed as a phase I, randomized, single-blind, parallel group,
placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour
administration of Cilastatin as stand-alone in healthy male and female volunteers.
The study will involve 24 healthy male and female healthy subjects, divided in three study
cohorts (8 subjects per cohort). The study is a dose escalating study, starting from 3 g of
Cilastatin administered intravenously in 3 hours.
Eight subjects will be randomized and assigned to either the study drug or placebo group for
each study cohort in a 3:1 ratio (6 actives and 2 placebos). Randomization will also be
gender balanced within each study cohort. The planned dose escalation scheme should not occur
before participants in the previous dose level have been treated and safety profile of
Cilastatin from those participants are assessed in accordande with the protocol.
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